MYLAN-ACYCLOVIR TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ACYCLOVIR

Fáanlegur frá:

MYLAN PHARMACEUTICALS ULC

ATC númer:

J05AB01

INN (Alþjóðlegt nafn):

ACYCLOVIR

Skammtar:

800MG

Lyfjaform:

TABLET

Samsetning:

ACYCLOVIR 800MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

NUCLEOSIDES AND NUCLEOTIDES

Vörulýsing:

Active ingredient group (AIG) number: 0115506005; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2009-07-03

Vara einkenni

_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 1 _
PRODUCT MONOGRAPH
PR
MYLAN-ACYCLOVIR
Acyclovir, USP
200, 400 and 800 mg Tablets
Manufacturer Standard
ANTIVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Control No.: 181160
DATE OF REVISION:
January 15, 2015
_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
AVAILABILITY OF DOSAGE FORMS
........................................................................
14
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................